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510(k) K800859

FETAL HEART DETECTOR #D206 by Sonicaid, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Sonicaid, Inc.

  • K873673 — BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (February 26, 1988)
  • K872074 — 5 MHZ TRANSDUCER (August 25, 1987)
  • K863803 — VASOPULSE(TM)/MODEL 5000 (May 6, 1987)
  • K862720 — VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (November 17, 1986)
  • K861237 — VASOVIEW DUPLEX IMAGING SYSTEM (July 14, 1986)
  • K851102 — VASOSCREEN IMPEDANCE PLETHYSMOGRAPH (May 16, 1985)
  • K833902 — VASOSCAN (January 27, 1984)
  • K832374 — PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (December 1, 1983)
  • K833488 — SONICOMP (November 28, 1983)
  • K833227 — SONICAID MODEL D206E AIR EMBOLI-DETECT (October 27, 1983)

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